Sacubitril/Valsartan for CKD5 Stage Dialysis Patients With Heart Failure

Sponsor

Ruijin Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05243199

Collaborator

(none)

600

Enrollment

Location

Arms

30.9

Anticipated Duration (Months)

19.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Hemodialysis or peritoneal dialysis CKD5 patients with heart failure were randomly divided into Sacubitril/Valsartan and irbesartan treatment groups. Comparing the survival rates, the cardiac function, renal function, blood pressure success rate, and adverse reactions of two groups, to evaluate whether the efficacy and safety of Sacubitril/Valsartan in the treatment of patients with CKD dialysis combined with heart failure is superior to that of irbesartan.

Condition or Disease	Intervention/Treatment	Phase
CKD5 Stage Dialysis Heart Failure	Drug: Sacubitril/Valsartan Drug: Irbesartan	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Sacubitril/Valsartan for Dialysis Patients With CKD5 Stage Complicated With Heart Failure- A Prospective, Randomized, Controlled Multicenter Study

Actual Study Start Date :

Aug 1, 2020

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sacubitril/Valsartan	Drug: Sacubitril/Valsartan The initial dose of 50mg Qd was increased to 50mg Bid after 1 week and maintained to 100mg Bid after 2 weeks if the patient could tolerate it (no follow-up exit criteria were found).
Active Comparator: Irbesartan	Drug: Irbesartan The Initial dose of 75 mg Qd with sand, such as patients can tolerate and follow-up exit criteria (not appear, to 75 mg Bid to maintain after 1 week, 2 weeks can still be tolerance is raised to 150 mg Bid.

Arm

Intervention/Treatment

Experimental: Sacubitril/Valsartan

Drug: Sacubitril/Valsartan

The initial dose of 50mg Qd was increased to 50mg Bid after 1 week and maintained to 100mg Bid after 2 weeks if the patient could tolerate it (no follow-up exit criteria were found).

Active Comparator: Irbesartan

Drug: Irbesartan

The Initial dose of 75 mg Qd with sand, such as patients can tolerate and follow-up exit criteria (not appear, to 75 mg Bid to maintain after 1 week, 2 weeks can still be tolerance is raised to 150 mg Bid.

Outcome Measures

Primary Outcome Measures

Rate of patients hospitalized for heart failure [1 year]
Hospitalization for worsening heart failure
Patient of survival rate [1 year]
Patient death (including death from cardiovascular events or other causes)

Secondary Outcome Measures

Rate of blood pressure compliance [1 year]
Blood pressure changes were followed up
Percentage of residual renal function improvement [1 year]
Follow up the changes of residual renal function

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

CKD stage 5, starting regular hemodialysis or peritoneal dialysis for more than 1 month.
NT-proBNP ≥2000pg/ml.
Voluntary informed consent.

Exclusion Criteria:

Unable to tolerate ACEI/ARB class antihypertensive drugs;
History of symptomatic hypotension/systolic blood pressure <100mmHg at screening;
Potassium >6.0mmol/L;
History of angioedema;
Abnormal liver function such as ALT and/or AST >=3 times normal upper limit (ULN), total bilirubin >= 2 times ULN;
Moderate to severe anemia (hemoglobin <80g/L);
Cardiac surgery/intervention/cardiac resynchronization therapy has been performed in the past 3 months or is planned in the next 12 months;
Newly found malignant tumor (within 3 years), or undergoing radiotherapy/chemotherapy;
Pregnant and lactating women, or those of childbearing age who are unable to guarantee effective contraception;
New and serious life-threatening infections;
Active infectious diseases such as active tuberculosis, active viral hepatitis and HIV infection;
Persons suffering from mental disorders and taking psychotropic drugs;
Patients with life expectancy less than 12 months;
The doctor assessed that the patient was not easy to follow up or had poor compliance and was not suitable for enrollment;
Patients who do not want to sign informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Nephrology, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University	Shanghai	Shanghai	China

Sponsors and Collaborators

Ruijin Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CHENNAN, Principal Investigator,Director,Foreign academicians of the French National Academy of Medical Sciences,Director of institute of Nephrology affiliated to Shanghai Jiao Tong University Medical College, Ruijin Hospital

ClinicalTrials.gov Identifier:

NCT05243199

Other Study ID Numbers: